Participants will learn about the key techniques and thought processes which may be used by auditors to maximize the benefits of each type of audit. These include planning and preparation, the audit team, structuring the audit, close out, CAPAs and follow up.
Suitable for: QA auditors and trainees. Production managers who receive internal QA and corporate GMP audits. Engineering managers who receive internal QA and corporate GMP audits. Production supervisors who lead Self Inspection audits. Auditors of suppliers and contractors
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Teachers and trainers (1)
Dr. David Inglis
David is director of Ulverston GMP Consulting Limited, specialising in GMP/Quality Assurance for the manufacturing sectors of the pharmaceutical and consumer healthcare industry. He has extensive experience in assessment and improvement of QA/GMP systems, auditing, GMP training, inspection preparation and plant cleaning / decontamination, especially in bulk intermediates and APIs. He has a PhD in enzyme chemistry (affinity chromatography).
This 2 day course is aimed at Quality Assurance auditors and production management for Level 2 internal audits and supplier auditing.
To be a business benefit rather than a drain on resources, your auditing programmes must be integral to continuous improvement. The key to effective internal auditing and auditing of suppliers is the training of both auditors and auditees in the purpose and relevant techniques of the audit and how these techniques can be channelled to achieve business and compliance improvements.
Part 1: Auditing Basics
- Reasons for audits and audit models (overview)
- The Purpose of Audits
- Role Characteristics of the Auditor
- Audit Types
- Audit Classification
- Audit Methods
- General Themes for All Audits
Part 2: Auditing Tools and Techniques
- Basic tools
- Audit Techniques
- Audit Planning
Part 3: The audit process
- Audit scheduling
- Conducting the audit
- Managing the Audit Team
- The Exit Meeting
- Audit Reporting
- Audit Closeout
Part 4: Improving the audit system
- Adding Value from the Audit programme
Part 5: Added Value from Self Inspections (Level2 – QA Led)
- A practical Level 2 inspection programme (based on Auditor Training)
- Purpose of the self inspection programme
- Establishing the programme
- Setting up and training the inspection team
- Conducting the inspection and reporting
The course will include three or four Workshops on specific aspects of Parts 1 to 4.